BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 10426865 · Received August 19, 2020

    Report

    Report Number
    1219930-2020-03418
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    May 3, 2020
    Report Date
    August 19, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: JOURNAL OF SURGICAL RESEARCH: EARLY POSTOPERATIVE BOWEL OBSTRUCTION OF APPENDECTOMY BECAUSE OF THE STAPLES IN PEDIATRIC PATIENTS SOURCE: HTTPS://DOI.ORG/10.1016/J.JSS.2020.05.001, VOLUME 254, P314-317, OCTOBER 01, 2020 ELSEVIER INC. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2014 TO 2018, A RETROSPECTIVE CHART REVIEW WAS PERFORMED OF PEDIATRIC PATIENTS UNDERGOING A LAPAROSCOPIC APPENDECTOMY THAT EXPERIENCED A SUBSEQUENT SMALL BOWEL OBSTRUCTION (SBO) WITHIN 6 WEEKS OF SURGERY. SIX OUT OF 793 PATIENTS WERE INCLUDED IN THE REVIEW. POST-OPERATIVELY, IT WAS REPORTED ONE PATIENT REMAINED HOSPITALIZED FOR PERSISTENT ILEUS, AND 3 PATIENTS REQUIRED URGENT SURGICAL EXPLORATION AFTER INITIALLY BEING TREATED WITH GASTRIC DECOMPRESSION AND FLUID RESUSCITATION FOR SYMPTOMS ASSOCIATED WITH A SBO. TWO OF THE 3 PATIENTS HAD ISCHEMIC BOWEL, ONE WAS DUE TO A TWISTING LOOP OF SMALL BOWEL, AND ONE WAS DUE TO AN INTERNAL HERNIA DUE TO ADHESIONS FROM THE STAPLE LINE TO THE TERMINAL ILEUM. THE AUTHOR NOTED STAPLES THAT WERE DROPPED WITHIN THE ABDOMINAL CAVITY AT THE INITIAL SURGERY WERE THE CULPRIT IN 4 OF THE 6 PATIENTS AND THESE PATIENTS REQUIRED REMOVAL OF THE FOREIGN BODY. ALL PATIENTS UNDERWENT IMAGING TO SUPPORT THE DIAGNOSIS OF A SBO. IT WAS REPORTED ONE PATIENT HAD A DROPPED STAPLE THAT CAUSED KINKING OF THE BOWEL AROUND AN INFLAMMATORY MASS. FOLLOWING THE SURGICAL INTERVENTION FOR TREATMENT OF THE SBO, ONE PATIENT HAD A SECOND SBO THAT REQUIRED ADDITIONAL SURGICAL INTERVENTION. AT RE-EXPLORATION, THIS PATIENT WAS FOUND TO HAVE A STAPLE UNFURLED AT THE END OF THE STAPLE LINE FOR THE APPENDECTOMY, CAUSING AN ADHESIVE BAND TO THE SMALL BOWEL MESENTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893291 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R